BEUDAMED
    18 results · 26ms · Sources: EU EUDAMED, US FDA

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    EYE FOR EYE

    Manufacturer
    🇫🇷 France

    IMAGINE EYES

    Manufacturer
    🇫🇷 France·1 Basic UDI-DI·1 Device·GMED SAS

    EYE TECH CARE

    Manufacturer
    🇫🇷 France

    EYE FIVE COMPANY

    Manufacturer
    🇫🇷 France

    Victoire Family Eyes

    Manufacturer
    🇫🇷 France

    ORASIS EYE ANALYTICS & REHABILITATION

    Manufacturer
    🇫🇷 France

    rtx1

    Device
    EU MDD · Eu Md Class 2a ·IMAGINE EYES·On the market·1 country

    7-AAD Viability Dye

    Device
    EU IVDR · Eu Ivd Class A ·IMMUNOTECH SAS ·On the market·32 countries

    rtx1 adaptive optics retinal camera

    Basic UDI-DI
    EU MDD · Eu Md Class 2a ·IMAGINE EYES·1 device

    Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·June 20, 2018

    VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·June 20, 2018

    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·June 20, 2018

    37824

    Certificate
    MDD Annex II (excluding section 4)·IMAGINE EYES·GMED SAS·1 Basic UDI-DI

    E>EYE C

    Basic UDI-DI
    EU MDD · Eu Md Class 2b ·E-SWIN SAS·1 device

    7-AAD Viability Dye

    Basic UDI-DI
    EU IVDR · Eu Ivd Class A ·IMMUNOTECH SAS ·1 device

    Laboratoires Théa

    Authorized representative
    🇫🇷 France·1 Manufacturer

    France Chirurgie Instrumentation SAS

    Importer
    🇫🇷 France·13 Manufacturers

    SANOTEK

    Importer
    🇫🇷 France·15 Manufacturers